EU-Clinical Trials Register - Sindbad

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Glossary of Terms used in EU Clinical Trials Register Term Parallel group Paediatric Investigation Plan (PIP) Patients p Pharmaceutical form Pharmacodynamic Pharmacoeconomic Pharmacogenetic Pharmacogenomic Pharmacokinetic Phase I Phase II Phase III Explanation A trial in which two or more treatments are evaluated concurrently in separate groups of patients. Document upon which the development and authorisation of medicinal products for the paediatric population is based. It is presented by an applicant early during the development of a product to the EMA Paediatric Committee in order to agree a paediatric development plan. Clinical Trial includes subjects, who are currently patients, and can also include healthy volunteers. A dosage form is the physical form of a dose of medication, such as a capsule or injection. The route of administration is dependent on the dosage. Pharmacodynamics is the exploration of what the Medicinal Product does to the body. Pharmacoeconomics refers to the scientific discipline that compares the value of one pharmaceutical drug or drug therapy to another. Pharmacogenetics is generally regarded as the study or clinical trial of genetic variation that gives rise to differing response to drugs. Pharmacogenomics is the broader application of genomic technologies to new drug discovery and further characterization of older drugs. Pharmacokinetics is the exploration of what the body does to a Medicinal Product. Phase I is the first stage of a clinical trial. It is to ensure a treatment is safe for people to take, rather than to try to treat a condition. These trials are very small, (typically around 30 people), and usually involve healthy volunteers or sometimes patients. Ref: http://www.mssociety.org.uk The second phase in clinical trials aims to investigate the safety and effectiveness of a potential therapy. Usually between 100 and 300 people will be enlisted to take part with the aim of determining whether the treatment will be safe and effective to treat a condition. If previous trials have indicated a treatment is safe and that it also shows promise in being able to treat a condition, phase III clinical trials begin. These involve large numbers of participants usually from several hundred to several thousand subjects, and are often spread between different hospitals and countries. If these trials show that a drug is safe and effective, the manufacturers can apply for a drug license. EMA/534108/2010 Page 8/12
Glossary of Terms used in EU Clinical Trials Register Term Phase IV PIP Addressee/Addressee of PIP Decision Placebo Planned number of subjects Post Trial Treatment Plasma derived medicinal product Preterm newborn infants Primary end point(s) Principal exclusion criteria Principal inclusion criteria Product code Product name Prophylaxis Explanation Post marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use. The PIP Addressee is the name given to the legal entity that has received the Agency's decision on a Paediatric Investigation Plan (PIP). A placebo is a control substance (a dummy treatment) that is given to people taking part in a clinical trial. It allows researchers to test for the 'placebo effect'. This is a psychological response where people feel better even though the substance they are taking has no effect. By comparing people's responses to the placebo and to the drug being tested, researchers can tell whether the drug is having any real benefit The number of subjects planned to be enrolled for a Clinical Trial Plans for treatment or care after the subject has ended the participation in the trial, if not already provided in the protocol A medicinal product derived from human blood or human plasma Subjects are not more than 37 weeks from their conception The main result that is measured at the end of a study to see if a given treatment worked (e.g., the number of deaths or the difference in survival between the treatment group and the control group). What the primary endpoint will be is decided before the study begins. Reasons for exclusion of subjects from the clinical trial from among the exclusion criteria described in the protocol Reasons for the inclusion of subjects in the clinical trial This is a code designated by the sponsor who represents the name routinely used by the sponsor to identify the product in the Clinical Trial documentation. In the absence of trade name this is the name routinely used by a sponsor to identify the IMP in the Clinical Trial Documentation Medical or public health measure taken whose purpose is to prevent, rather than treat or cure a disease. Primary prophylaxis is generally intended to prevent the development of a disease, while secondary prophylaxis is intended to prevent the disease, once contracted by a patient, from worsening EMA/534108/2010 Page 9/12
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EU-Clinical Trials Register - Sindbad

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